DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 6/11/26 have been fully considered but they are not persuasive.
The argument that De Ridder uses uncoordinated sequences or uncoordinated burst stimulation and that the claims call for “randomized coordinated reset stimulation” is not persuasive.
The applicants and the prior art inventors can be their own lexicographer. For example, while one patent may call 10 volts a “high” voltage, another applicant may call 10 volts a “low” voltage. This is the same situation occurring in this application and prior art. The question that needs answered is “does the prior art meet the limitations as set forth in the present claims?”. The answer is yes.
The applicant has set forth the limitations of what they consider “randomized coordinated reset stimulation” (e.g. para. 11, etc.) in that the stimulation has consecutive time windows with a pulse in each time window of a given electrode that has at least one of the amplitude or the time of the pulse randomly varied in each consecutive time window.
De Ridder discloses these exact claim limitations (e.g. figure 10, discussed below in the 102 rejection) and therefore meets the claim limitations, and applicant’s definition, of “randomized coordinated reset stimulation”. If there is another definition of what the claimed “randomized coordinated reset stimulation” contains, then the applicant should specifically state what this definition/meaning is in the response so the examiner can consider it and determine whether De Ridder contains that updated definition/meaning. It does not matter that the applicant and De Ridder have different terms for the same element, as both can be their own lexicographer and/or both are not limited to the terms of what the other uses.
The applicant further argues that De Ridder does not have randomly varying amplitude in the stimulation (i.e. claims 5, 6, 12, 13, 15) and that the randomly varying amplitude is used just for feedback. This is not persuasive as De Ridder discloses the randomly varying amplitude is used in the burst stimulation, and whether it is used for feedback or not is not relevant as the claims do not preclude this. The applicant further argues the 103 of Steinke in view of De Ridder and that De Ridder cannot be used since it is uncoordinated stimulation, and for similar reasons as discussed above, the arguments are not persuasive.
The applicant’s argument that Steinke’s figure 8 is just for a single electrode and not for multiple electrodes is not persuasive as a reading of Steinke, and as set forth previously in the 102 rejection below, Steinke states that the examples of the single electrode configuration, such as figure 8, can be used for multiple electrodes (e.g. para. 46, para. 35, etc.). Note also the claims only state that the random variation of time or amplitude is for “a given electrode” of the plurality of electrodes, and not that each electrode of the plurality of electrodes is randomly varying the time or amplitude of the stimulation in the consecutive windows.
The applicant argues the 103 rejection of claims 2, 3, 9, and 10, asking for evidence of the well-known in the art elements. It is noted that to adequately traverse a finding based on official notice, an applicant must specifically point out the supposed errors in the examiner’s action, which would include stating why the noticed fact is not considered to be common knowledge or well-known in the art. A mere request by the applicant that the examiner provide documentary evidence in support of an officially-noticed fact is not a proper traversal. See 37 CFR 1.111(b). See also Chevenard, 139 F.2d at 713, 60 USPQ at 241. Saying that, evidence has been provided with this office action showing the use of random amplitude stimulation using uniform and binary/binomial/Bernoulli distributions, such as in Zhu (paras. 56-62, 78, etc.), Nelson (paras. 52-54, 123-128, etc.), and/or Mishra (paras. 58-61, 251, 408-409, etc.).
The 102 rejection for Steinke on claims 4 and 11 has been withdrawn as claims 4 and 11 positively recite the time being varied.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-15 are rejected under 35 U.S.C. 102a1 as being anticipated by De Ridder (WO 2020/099921). Note that for claims 2, 3, 9, and 10, that the claims are dependent on what is selected in claim 1/8. For example, if in claim 1, line 11, for the “wherein at least one of”, if the last two lines of the claim are selected of random varying the time of the electric pulse, then claims 2, 3, 9, and 10 are automatically met even though they may not be in the prior art, since claims 2, 3, 9, and 10 base their limitations on an element that was not selected (i.e. the respective amplitude).
De Ridder discloses the claimed invention as follows:
--a plurality of electrodes (e.g. figures 1 and 2, figure 10, electrodes 1004 and 1005, etc.)
--a neurostimulator coupled to the electrodes (e.g. figure 1, etc.) to deliver randomized coordinated reset stimulation to the brain for treatment of motor symptoms of Parkinson’s (e.g. paras. 2, 56, 7, 12, 58, etc.)
--the stimulation having a plurality of consecutive time windows (e.g. figure 10, cycle 1034, cycle 1036, para. 70, etc.)
--wherein at least one of…” the respective time of the electric pulse for a given electrode in the plurality of electrodes is randomly varied in each consecutive time window” (e.g. figure 10, cycle 1034 and 1036, electrodes 1004 and 1005, etc.)
For claims 2, 3, 9, and 10, since the respective time has been chosen for claims 1 and 8, these claims are met since they are directed to the respective amplitude which was not chosen. For claims 5, 6, 12, 13, and 15, De Ridder also discloses that the amplitude in each of the randomly varied pulse bursts may be varied (e.g. paras. 7, 11, 55, 56, etc.).
Claims 1, 7, 8, and 14 are rejected under 35 U.S.C. 102a1 as being anticipated by Steinke et al (2018/0345022). Steinke discloses the claimed invention as follows:
--a plurality of electrodes (e.g. figures 1 and 8, elements E, etc.)
--a neurostimulator coupled to the electrodes (e.g. figure 1, etc.) to deliver randomized coordinated reset stimulation to the brain for treatment of motor symptoms of Parkinson’s (e.g. title, paras. 5, 33, etc.)
--the stimulation having a plurality of consecutive time windows (e.g. figure 8, t1, t2, t3, etc.)
--wherein at least one of…” the respective amplitude…time window” (e.g. figure 8, t1, t2, t3, etc., paras. 42-43, para. 46 discussing using it from multiple electrodes)
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2, 3, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Steinke et al. Steinke discloses the claimed invention using random variance of the amplitude of the electric pulse but does not disclose the use of a uniform distribution or binary distribution for the variance. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed (and is admitted prior art as the applicant has not pointed out the errors in the examiner’s findings and/or provided evidence of non-obviousness) to have modified the system and method as taught by Steinke, with the use of a uniform distribution or binary distribution for the variance, as is well known and common knowledge in the art (mpep 2214I, 2144.03), since it would provide the predictable result of allowing an equal probability for all outcomes/values to be chosen eliminating bias toward one amplitude (uniform distribution) or allowing the determination of the amplitude value to be faster and computationally cheaper/easier (binary distribution).
Claims 4-6, 11-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Steinke et al in view of De Ridder. Steinke discloses the claimed invention using random variance of the amplitude and other additional types of random coordinated reset stimulation to the brain, such as pulse width, pulse shape, etc., but does not disclose also using an additional type of randomly varying stimulation of varying the time of the electric pulse for the electrodes in each consecutive window. De Ridder teaches that it is also known to randomly vary the time of the electric pulse for the electrodes in each consecutive window to provide an effective way to provide random coordinated reset stimulation for DBS. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by Steinke, with the additional type of random variation stimulation of randomly varying the time of the electric pulse for the electrodes in each consecutive window, as taught by De Ridder, since it would provide the predictable results of providing an additional/substitute way to provide random coordinated reset stimulation for DBS to effectively treat the patient.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/George R Evanisko/Primary Examiner, Art Unit 3792 8/27/26
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